Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00006473

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Condition or Disease	Intervention/Treatment	Phase
Angioimmunoblastic T-cell Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Waldenström Macroglobulinemia	Drug: oxaliplatin	Phase 2

Detailed Description

OBJECTIVES:

Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
Determine the treatment-related toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma

Study Start Date :

Sep 1, 2000

Actual Primary Completion Date :

Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (oxaliplatin) Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.	Drug: oxaliplatin Given IV Other Names: 1-OHP Dacotin Dacplat Eloxatin L-OHP

Arm

Intervention/Treatment

Experimental: Treatment (oxaliplatin)

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin

Given IV

Other Names:

1-OHP

Dacotin

Dacplat

Eloxatin

L-OHP

Outcome Measures

Primary Outcome Measures

Response rate [Up to 6 years]
Using a Simon's two-stage model.

Secondary Outcome Measures

Duration of response [Up to 6 years]
Analyzed using the Kaplan-Meier method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
Indolent
Follicular small cleaved cell
Follicular mixed cell
Small lymphocytic
Mucosa-associated lymphoid tissue (MALT)
Monocytoid B-cell
Waldenstrom's macroglobulinemia
Aggressive
Follicular large cell
Diffuse large cell
Immunoblastic
Mantle cell
Ki-1+ NHL
Peripheral T-cell
Angiocentric and angioimmunoblastic
Transformed lymphoma
Bidimensionally measurable disease
No more than 3 prior treatment regimens as follows:
Primary radiotherapy is 1 regimen
Combined therapy with radiotherapy and chemotherapy is 1 regimen
Alternating therapy is 1 regimen
No known brain metastases
Performance status - ECOG 0-2
Performance status - Karnofsky 50-100%
WBC count at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin normal
SGOT/SGPT no greater than 2.5 times upper limit of normal
Creatinine normal
Creatinine clearance at least 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No neuropathy greater than grade 1
No history of allergy to platinum compounds or antiemetics
No uncontrolled illness
No active infection
Not pregnant or nursing
Fertile patients must use effective contraception
No concurrent colony-stimulating factors during first course of therapy
At least 4 weeks since prior chemotherapy
At least 4 weeks since prior radiotherapy
No other concurrent investigational drugs
No concurrent antiretroviral therapy for HIV-positive patients